Status:

RECRUITING

A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD

Lead Sponsor:

Weill Medical College of Cornell University

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Depression

Pain

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive...

Detailed Description

This is a Randomized Control Trial to target cognition in older adults with MCI or Early AD, depression, and chronic pain with a psychotherapeutic intervention in primary care. This project will study...

Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 60 years old
  • MCI or early stage probable or possible AD diagnosis (as defined by Albert et al or McKhann et al) al). Patients will have at least mild cognitive deficits defined by 16 ≤ MoCA ≤ 25.
  • Montgomery Asberg Depression Rating Scale (MADRS)[55] total ≥ 5, which reflects at least some mild depressive symptoms.
  • Participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks.
  • Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score >=4.
  • Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1.
  • Participant will have capacity to consent.
  • Participation of a study partner (e.g. caregiver/family member/significant other) is required.

Exclusion Criteria:

  • Deemed to have a significant suicide risk as assessed by site PI and clinical team.
  • Deemed too unstable medically or neurologically to safely enroll in a research trial.
  • Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy.
  • Requiring psychiatric hospitalization at baseline for safety.
  • Lack of English fluency.

Key Trial Info

Start Date :

June 3 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05081596

Start Date

June 3 2022

End Date

July 31 2027

Last Update

May 23 2025

Active Locations (1)

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1

Weill Cornell Medicine

White Plains, New York, United States, 10502